Solutions
Software Lifecycle Development
In both the medical device industry and broader enterprise environments, effective management of the software lifecycle is critical to ensuring the quality, safety, and compliance of software applications. Whether developing Software in Medical Devices (SiMD), Software as a Medical Device (SaMD), Multiple Function Devices, or non-product software applications, organizations need a comprehensive approach to software development that integrates best practices, regulatory compliance, and risk management. Qualified Data Systems (QDS) offers a specialized Software Lifecycle Development Solution that supports the unique needs of both product and non-product software across all stages of the development lifecycle.
Solution Activities
Requirements Management and Design Planning
- Comprehensive Requirements Gathering: QDS facilitates thorough requirements gathering to ensure that all functional, non-functional, and regulatory requirements are clearly defined and documented at the outset of the project. Our approach ensures alignment with business goals, user needs, and compliance obligations.
- Design Planning and Documentation: We help organizations develop detailed design plans that outline the architecture, components, interfaces, and data flows for both product and non-product software. Our design planning services ensure that your software is built on a solid foundation that supports scalability, maintainability, and security.
- Risk Management Integration: QDS integrates risk management into the design planning process, ensuring that potential risks are identified and mitigated early in the development lifecycle. Our approach aligns with ISO 14971 and other relevant standards to ensure that safety and compliance are prioritized from the beginning.
Agile and Traditional Development Methodologies
- Agile Software Development: For organizations seeking flexibility and faster time-to-market, QDS offers Agile development services that emphasize iterative development, continuous feedback, and rapid adaptation to changing requirements. Our Agile approach is particularly well-suited for dynamic environments and innovative projects.
- Waterfall and Hybrid Development Models: QDS also supports traditional Waterfall and hybrid development models, which may be more appropriate for certain types of projects, especially those with well-defined requirements and regulatory constraints. We ensure that each phase of development is meticulously planned, executed, and documented.
- DevOps Integration: To enhance collaboration between development and operations teams, QDS offers DevOps integration services that automate the software delivery process, improve code quality, and enable continuous integration/continuous deployment (CI/CD). Our DevOps practices ensure that your software is delivered faster, with fewer errors and greater reliability.
Verification, Validation, and Testing
- Comprehensive Testing Strategies: QDS develops and implements comprehensive testing strategies that cover all aspects of software verification and validation, including unit testing, integration testing, system testing, and user acceptance testing (UAT). Our testing services ensure that your software meets all functional, performance, and compliance requirements.
- Automated Testing Solutions: We offer automated testing solutions that increase testing efficiency, coverage, and repeatability. Our automated testing frameworks are designed to integrate seamlessly with your development environment, reducing the time and effort required for manual testing.
- Compliance Validation: QDS ensures that your software undergoes rigorous validation to meet regulatory standards such as FDA 21 CFR Part 820, IEC 62304, and ISO 13485. Our validation services include the development and execution of validation protocols, test case documentation, and traceability matrices to ensure that your software is compliant and audit-ready.
Regulatory Documentation and Compliance Support
- Regulatory Documentation Preparation: QDS assists in the preparation of all necessary regulatory documentation required for product approval and certification. This includes Software Design History Files (DHF), Software Requirements Specifications (SRS), Software Verification and Validation Plans, and Risk Management Files.
- Audit Support and Compliance Management: We provide ongoing support to help organizations maintain compliance throughout the software lifecycle. QDS offers audit preparation services, including mock audits, documentation reviews, and remediation planning to ensure that your software is always ready for regulatory inspection.
- Post-Market Compliance: For SaMD, SiMD, and Multiple Function Devices, QDS offers post-market compliance services, including software updates, change management, and cybersecurity risk assessments. Our post-market services ensure that your software remains compliant and secure throughout its lifecycle.
Lifecycle Maintenance and Continuous Improvement
- Software Maintenance and Updates: QDS provides ongoing software maintenance and support services to ensure that your software remains functional, secure, and up-to-date. We manage software updates, bug fixes, and enhancements to extend the life of your software and maximize its value.
- Continuous Improvement Programs: We help organizations implement continuous improvement programs that leverage data analytics, user feedback, and performance metrics to identify areas for enhancement. QDS ensures that your software evolves to meet changing user needs and regulatory requirements.
- Legacy System Modernization: For organizations with existing legacy systems, QDS offers modernization services to update and improve outdated software. Our modernization services include code refactoring, platform migration, and integration with modern technologies to ensure that your software remains relevant and effective.
Industry Focus
QDS specializes in providing Software Lifecycle Development solutions for the following sectors:
- Medical Devices (SiMD and SaMD): Supporting the development of software integrated into medical devices and standalone medical software, ensuring compliance with FDA, EMA, and other regulatory bodies.
- Multiple Function Devices: Managing the complexities of devices that combine multiple functions, including medical and non-medical software, ensuring that all components meet regulatory standards.
- Enterprise Software (Non-Product Applications): Enhancing the development, deployment, and maintenance of enterprise software applications, such as ERP, CRM, and business intelligence tools, ensuring alignment with corporate governance and operational goals.
Value Proposition
QDS’s Software Lifecycle Development Solution offers the following benefits:
Our solution ensures that your software meets all relevant regulatory requirements, reducing the risk of non-compliance and facilitating smoother regulatory approvals.
By integrating best practices in design, development, and testing, we help ensure that your software is of the highest quality, safe for use, and reliable in operation.
Our support for both Agile and traditional development methodologies provides the flexibility to choose the best approach for your project, whether you need rapid iteration or detailed planning.
QDS’s DevOps integration and automated testing solutions streamline the software development process, reducing time-to-market, improving code quality, and enhancing overall efficiency.